Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

— IMRT  

Official title:

Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04136886
• Other study ID #: B2019-070-01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2020
• Est. completion date: December 2027

Study information

• Verified date: October 2019
• Source: Sun Yat-sen University
• Contact: Fei Han, doctor
• Phone: 8620-87343030
• Email: hanfei[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Description:

Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 346
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;

2.No evidence of distant metastasis

3.More than 1 year from the end of the first course of radiotherapy

4.Male, or female not in the phase of lactating or pregnancy

5.ECOG 0-2

6.Aged 18-70 years old

7.WBC count =4×109/L, neutrophile granulocyte count=1.5×109/L, PLT count =100×109/L, Hb =9g/L

8.Total bilirubin, AST, ALT=2.0 times of upper normal limits; creatinine =1.5 times of upper normal limits

9.Written informed consort signed

Exclusion Criteria:

1. Only regionally recurrence

2. Evidence of distant metastasis

3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted

4. Severe, active co-morbidity

5. Prior anti-tumor treatment after diagnosis of local recurrence

6. MRI was not performed 3 months after the first course of radiotherapy

7. Abnormal function of heart, brain and lungs, etc

8. Lactation or pregnancy

9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Cisplatin
cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction

Radiation:
• IMRT
Radiation: IMRT IMRT is to give 60Gy in 27 fraction

Locations

Country	Name	City	State
China	WangHanYu	Guangzhou	Guangdong

Sponsors (12)

Lead Sponsor

Collaborator

Sun Yat-sen University

Affiliated TongJi hospital of HuaZhong University of science and Technology, First Hospital of FoShan City, Fujian Province Tumor Hospital, GuiZhou Province Tumor Hospital, HaiNan Province Tumor Hospital, Hunan Province Tumor Hospital, JiangXi Province Tumor Hospital, Second Affiliated Hospital of Nanchang University, SiChuan Province Tumor Hospital, Wuhan University, YuNan Province Tumor Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Guan Y, Liu S, Wang HY, Guo Y, Xiao WW, Chen CY, Zhao C, Lu TX, Han F. Long-term outcomes of a phase II randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasophar — View Citation

Han F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29. — View Citation

Seo Y, Yoo H, Yoo S, Cho C, Yang K, Kim MS, Choi C, Shin Y, Lee D, Lee G. Robotic system-based fractionated stereotactic radiotherapy in locally recurrent nasopharyngeal carcinoma. Radiother Oncol. 2009 Dec;93(3):570-4. doi: 10.1016/j.radonc.2009.10.018. Epub 2009 Nov 16. — View Citation

Xiao WW, Huang SM, Han F, Wu SX, Lu LX, Lin CG, Deng XW, Lu TX, Cui NJ, Zhao C. Local control, survival, and late toxicities of locally advanced nasopharyngeal carcinoma treated by simultaneous modulated accelerated radiotherapy combined with cisplatin concurrent chemotherapy: long-term results of a phase 2 study. Cancer. 2011 May 1;117(9):1874-83. doi: 10.1002/cncr.25754. Epub 2010 Nov 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		From the beginning the IMRT to 3 year after the end of IMRT
Secondary	Number of participants with severe acute toxicities as assessed by CTCAE v3.0		From the beginning of IMRT to 3 months after the end of IMRT
Secondary	Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema		From 3 months after the end of IMRT to 1 year after the end of IMRT